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. 2014 May 28;2014(5):CD003895. doi: 10.1002/14651858.CD003895.pub3

Frifelt 1996.

Methods
  • Study design: parallel RCT

  • Study duration: NS

  • Duration of follow‐up: NS

Participants
  • Country: Denmark

  • Setting: single centre

  • Hb < 9.7 g/dL; CAPD ≥ 3 months; age ≥ 18 years; rHuEPO started and adjusted before randomisation to reach target Hb 10.5 to 12.0 g/dL

  • Number: treatment group 1 (16); treatment group 2 (17)

  • Mean age ± SD (years): NS

  • Sex (M/F): NS

  • Exclusion criteria: immunosuppressive therapy; moderate or severe hypertension; anaemia due to other causes

Interventions Treatment group 1
  • rHuEPO: SC once/wk for 3 months starting at 60 U/kg/wk

  • Doses adjusted to maintain target Hb


Treatment group 2
  • rHuEPO: SC 3 times/wk for 3 months starting at 60 U/kg/wk

  • Doses adjusted to maintain target Hb


Other information
  • Type of EPO: recormon beta


Co‐interventions
  • IV and oral iron supplementation

Outcomes
  • Hb levels at end of study

  • rHuEPO doses end of study

Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "randomised, prospective study"
Allocation concealment (selection bias) Unclear risk Not mentioned
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Primary outcome was laboratory based and not likely to be influenced by blinding
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Primary outcome was laboratory based and not likely to be influenced by blinding
Incomplete outcome data (attrition bias) 
 All outcomes High risk 15% (6/39) excluded and missing data could have influenced final result; peritonitis (4); cerebral ischaemia (1); death due to AMI (1)
Selective reporting (reporting bias) High risk No reports on mortality and incomplete reporting of adverse effects. Results available only as median and IQR and cannot be entered in meta‐analyses
Other bias High risk Funded study by Ercopharm, Kvistgaard, Denmark